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Bayer says FDA grants priority review designation for finerenone

The logo of Bayer at the company’s booth at the 8th China International Import Expo (CIIE) in Shanghai, China, November 6, 2025. REUTERS/Maxim Shemetov
The logo of Bayer at the company’s booth at the 8th China International Import Expo (CIIE) in Shanghai, China, November 6, 2025. REUTERS/Maxim Shemetov Reuters

Bayer said on Thursday that the U.S. Food and Drug Administration had accepted its supplemental New Drug Application for finerenone and granted priority review designation.

Finerenone, marketed as Kerendia, is used for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes.

Bayer said the application is supported by a study showing finerenone reduced the primary endpoint - the urine albumin-to-creatinine ratio - by about 25% from baseline over six months versus placebo in adults with CKD associated with type 1 diabetes.

(Reporting by Paolo Laudani, Editing by Friederike Heine)

Copyright Reuters or USA Today Network via Reuters Connect

This story was originally published May 22, 2026 at 4:37 AM.

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